A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

Conditions

• Plaque Psoriasis

Eligibility Criteria

Sex

ALL

Age

4 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Zasocitinib — DRUG
  Zasocitinib.
• Placebo — DRUG
  Zasocitinib matching placebo.
• Zasocitinib — DRUG
  Zasocitinib.

Study Details

The main aim of this study is to see how well the medicine zasocitinib works, how safe it is, and how children and teenagers aged 4 to under 18 with moderate-to-severe plaque psoriasis respond to it. The study will be done in 2 parts: Part A will include both children and teenagers, while part B will only include children. At first, only teenagers who meet the study rules can participate in this study. Children may only start to participate once enough information has been collected from other studies with zasocitinib. Participants in Part A will initially be assigned to receive either zasocitinib or placebo for the first 16 weeks of treatment, then all participants will receive zasocitinib through the end of the study. All participants in Part B will be assigned to receive treatment with zasocitinib throughout the study. Participants will be in the study for up to 4 years and 2 months (217 weeks), including up to 35 days for the screening period, 208 weeks of treatment (Part A and Part B) and a 4-week safety follow-up period. During the study, participants will visit their study site multiple times.

Key Dates

Start date

Dec 4, 2025

Status verified

May 2026

Primary completion

Jan 24, 2033

Completion

Jan 24, 2033

Study Design

Enrollment

110 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part A (Cohort 1): Zasocitinib (Dose A)
  Participants (Adolescent) aged 12 to less than (\<)18 years will receive zasocitinib Dose A once daily (QD), orally, from Week 1 to Week 16 during the double-blind placebo-controlled period followed by zasocitinib, from Week 16 to Week 208 during the open-label period.
• Experimental: Part A (Cohort 2): Zasocitinib (Multiple Doses)
  Participants (Children) aged 4 to \<12 years will receive zasocitinib, orally, doses based on weight, from Week 1 to Week 16 during the double-blind placebo-controlled period followed by zasocitinib from Week 16 to Week 208 during the open-label period.
• Placebo Comparator: Part A (Cohort 1 and Cohort 2): Placebo
  Participants in Cohort 1 (Adolescent aged 12 to \<18 years) and Cohort 2 (Children aged 4 to \<12 years) will receive zasocitinib matching placebo QD from Week 1 to Week 16 during the double-blind placebo-controlled period.
• Experimental: Part B: Zasocitinib (Multiple Doses)
  Participants (Children) aged 4 to \<12 years will receive zasocitinib, orally, doses based on weight, from Week 1 to Week 208 during the open-label period.

Primary Outcome Measure

Part A: Percentage of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a Greater than or Equal to (>=) 2-Point Decrease From Baseline at Week 16 [ Time Frame: At Week 16 ]

Central Contacts

• Takeda Contact
  +1-877-825-3327
  [email protected]

Locations (11)

Find similar trials in Chula Vista, CA

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